Metaplasticity in Human Pharyngeal Motor Cortex

University of Manchester

Status: Completed

Conditions: Deglutition; Physiology

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03705936

2018-4900-7208

Details and patient eligibility

About

The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.

Full description

Recent studies have suggested that repetitive transcranial magnetic stimulation (rTMS), which is a well-established and tried and tested non-invasive (no surgical procedures involved) brain stimulation technique that can vary brain activities, may be used as a treatment for patients with swallowing difficulties. However, results have also showed that the response to the treatment is different among individuals. A possible explanation for this variation is related to the brain's level of activity preceding rTMS. The hypothesis of this study is that this variation may be minimized by regulating the brain state with an additional dose of rTMS prior to the intended rTMS session (preconditioned rTMS). This may subsequently improve the outcomes of rTMS.

Therefore, this study aims to better regulate the response of the brain to rTMS. The findings of this study will provide the basis for future development of optimal rTMS treatment protocols for patients with swallowing difficulties.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers aged 18 years old or above; and
• No medical complications or significant past medical history

Exclusion criteria

• History of epilepsy;
• Previous history of neurosurgery;
• Previous swallowing problem;
• Implanted brain electrodes, cardiac pacemaker; or
• Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 8 patient groups

Sham 1Hz rTMS--5Hz rTMS

Sham Comparator group

Description:

Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS.

Treatment:

Device: rTMS

1Hz rTMS--5Hz rTMS

Experimental group

Description:

Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS.

Treatment:

Device: rTMS

1Hz rTMS--30-minute break--5Hz rTMS

Experimental group

Description:

Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS.

Treatment:

Device: rTMS

1Hz rTMS--60-minute break--5Hz rTMS

Experimental group

Description:

Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS.

Treatment:

Device: rTMS

Sham 5Hz rTMS--1Hz rTMS

Sham Comparator group

Description:

Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS.

Treatment:

Device: rTMS

5Hz rTMS--1Hz rTMS

Experimental group

Description:

Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.

Treatment:

Device: rTMS

5Hz rTMS--45-minute break--1Hz rTMS

Experimental group

Description:

Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS.

Treatment:

Device: rTMS

5Hz rTMS--90-minute break--1Hz rTMS

Experimental group

Description:

Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS.

Treatment:

Device: rTMS